Nonrulemaking

Requests that the FDA Refuse to approve the Glenmark generic topical clobetasol propionate product submitted under ANDA 214191, and any similarly formulated generic products, because there is a reasonable basis to conclude that Glenmark made formulation changes, including significant changes to the vehicle, that likely increase absorption and raise unanswered questions of safety and effectiveness

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Rules, notices, and supporting material — the primary rule pinned first.